临床领域,您唯一的OEM供应商

在OEM医疗产品的领域内,为您提供高品质的一次性流体控制产品和解决方案

Elcam’s Product Development Process

  • Ideas
  • Design & Development
  • Manufacturing Engineering
  • Manufacturing
  • QA & Regulatory
  • Marketing & Sales
  • Latest Solutions
  • Post Marketing Activities

Ideas

We at Elcam Medical, by close cooperation with OEM customers, key clinicians and inventors are exploring the medical market on a day to day basis. We are acquainted and committed to medical market needs, trends, benchmarks and are providing high quality feasible evaluations.

Design & Development

Our Design and Development Engineering team through its vast experience, creativity and application of up to date engineering tools, is qualified to give the best advice and support in cost-effective design, raw material, product features and specifications, in accordance with the design control requirements of 21 CFR part 820.30 and ISO 13845 : 2016.

Manufacturing Engineering

Elcam Medical's initial capabilities are rooted in manufacturing, injection molding and automatic assembly. Our Process Engineering team transforms prototypes into manufacturable, cost-effective, validated devices, as well as developing and adjusting specially designed production lines in our Class 8 (ISO 14644) clean rooms.

Manufacturing

State of the art tooling, multi-cavity and 2C (two-components) molds in versatile injection machines produce the parts, which are then assembled in our fully automated assembly lines, under strict Quality Control of the entire process all the way down to the warehouse. The barcode identified lots are stored and dispatched by computerized logistics - providing full traceability for each product delivered to the customer.

QA & Regulatory

Our robust QA and Regulatory system provides confidence in design, manufacturing and distributing cleared/approved, reliable devices that comply with relevant regulatory requirements and strictest standards of the medical device industry. Elcam is committed to working according to all applicable laws and regulations and our quality management system aims to maintain its ISO 13485 certification and compliance with 21 CFR 820 throughout the products life cycle.

Marketing & Sales

Through our extended marketing system, Elcam Medical's Marketing & Sales teams at the Headquarters and at our offices in the US, Europe, the Far East and in South America, promote and distribute our products worldwide. Elcam markets their products through 160 companies in the US, 230 in Europe, and over 550 companies worldwide.

Latest Solutions

Elcam Medical has already successfully implemented this model for our customers and their products, covering a wide range of medical areas and in multiple technologies. Examples of such products are the Disposable Integrated Pressure Transducer, the SafePort™ Manifold and our Marvelous™ Stopcock. Elcam is developing other technologies to be marketed with user-needs in mind, with a special emphasis on enhanced patient & caregiver safety.

Post Marketing Activities

The regulatory responsibility for Elcam’s products comprises of the entire product life cycle, form early development stages through post marketing follow up, including incident reporting and filed action requirements, if required.

创新

爱康医疗器械公司研发、制造和销售用于静脉注射、病人监护、透析及心脏介入和放射介入的创新性医疗系统、设备和器件。我们的产品致力于改善患者和护理人员的安全问题,诸如减少血液感染、降低管路的连接错误和断开的可能性,以及保护医务人员暴露于传染病或有害药物。

关心我们的客户及其成功是我们的创新动力。
我们基于客户的需求而创新,为客户提供针对实际问题的真正解决方案,以提升他们的竞争优势。

 

 

联系方式

品质的保证

在保证产品品质的前提下,爱康医疗有丰富的经验来保证我们的交货期。我们严格遵守 ISO 13485 : 2016。我们大多数的产品都有CE和510(K)认证。

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